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BISandISO
1.ISO&BISSubmittedTo:Prof.TejalShahSubmittedBy:DixitaPatel(Pharma)HiranPatel(IB)Jaan
Patel(Pharma)JyotiPatel(Agri)
2.ISO(Internationalorganizationforstandardization)
3.WHATISISO? ISOisaninternationalagencyconsistingof156membercountriesincludingKenya.
ISOwasformedin1947andisbasedinGeneva,Switzerland. Itdevelopsinternationalstandardsto
fosterincreasedtradeofproductsandservices. ByJuly2005,ISOhadpublishedover15,000standards
.
4.ISOORGANIZATIONGeneralAssemblyCouncilPolicyDevelopmentcommittesTechnicalManagement
BoardTechnicalAdvisoryGroupTechnicalCommittees
5.ISOSTANDARDS ISOInternationalstandardsensurethatproductsandservicesaresafe,reliableand
ofgoodquality. TheInternationalorganizationforstandardizationisaworldwidefederationofnational
standardbodies. Workingthroughtechnicalcommittees,ithasdevelopedandpublishedover18000
differentISOstandardsthatareusedinternationallyforsubjectsrangingfromfilmspeedstowineglasses
toqualitymanagementsystems.
6. TheofficialpurposefortheissuanceofISOstandardsistofacilitateworldtradethrough
standardization. Forbusinesstheyarestrategictoolsthatreducecostsbyminimizingwastesanderrors,
andincreasingproductivity. Theyhelpcompaniestoaccessnewmarkets,leveltheplayingfieldfor
developingcountriesandfacilitatefreeandfairglobaltrade. Foundedon23feb1947,theorganization
promotesworldwideproprietary,industrialandcommercialstandards.
7.SOMEPOPULARSTANDARDS ISO9001Qualitymanagement ISO14001Environmental
management ISO3166Countrycodes ISO26000Socialresponsibility ISO50001Energy
management ISO31000Riskmanagement ISO22000Foodsafetymanagement
8.STAGESFORREGISTRATION Submitapplicationtoregistrar. Stage1:assessmentofreadiness
Stage2:assessmentforregistrationaudit Registration/certificationawardedfor3years Surveillance
audit Recertificationauditattheendof3rdyear.
9.ISO9001AND14001STANDARDS ISO9001AND14001arethemostpopularstandardsamongstall
others. Theyareimplementedbyamorethenamillionorganizationsinsome175countries. ISO9001
helpsorganizationstoimplementqualitymanagement. ISO14001helpsorganizationstoimplement
environmentalmanagement. BothISO9001and14001aregenericstandards. Genericmeansthat
thesamestandardscanbeappliedtoanyorganization,largeorsmall,inanysectorofactivity,whetherits
abusinessenterprise,oragovernmentdepartment.
10.ISO9001(QUALITYMANAGEMENT) Qualityreferstoallthosefeaturesofaproductorservice
whicharerequiresbythecustomer. Qualitymanagementmeanswhattheorganizationdoestoensure
thatitsproductsorservices,satisfythecustomersqualityrequirementsandcomplywithanyregulations
applicabletothoseproductsorservices. Qualitymanagementalsomeanswhattheorganizationdoesto
enhancecustomersatisfactionandachievecontinualimprovementofitsperformance.
11.THEISO9000FAMILY ISO9001isthestandardthatgivestherequirementsforaquality
managementsystem. ISO9001:2008isthelatest,improvedversion. ItistheonlystandardintheISO
9000familythatcanbeusedforcertification. Thereare16otherstandardsinthefamilythatcanhelpan
organizationonspecificaspectssuchasperformanceimprovement,auditing,training
12.WHYADOPTISO9000? TocomplywithcustomerswhorequireISO9000 TosellintheEuropean
Unionmarket Tocompeteindomesticmarkets Toimprovethequalitysystem Tominimizerepetitive
auditingbysimilaranddifferentcustomers Toimprovesubcontractorsperformance
13.ISO14001 Thisisforenvironmentmanagement. Environmentmanagementmeanswhatthe
organizationdoestominimizeharmfuleffectsontheenvironmentcausedbyitsactivities,toconformto
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applicableregulatoryrequirementsandtoachieveimprovementofitsenvironmentperformance. ISO
14000includes21otherstandardsthatcanhelpanorganizationspecificaspectssuchasauditing,
environmentlabelling,lifecycleanalysis,etc.
14.THEISO14000FAMILY ISO14001isthestandardthatgivestherequirementsforanenvironmental
managementsystem. ISO14001:2004isthelatest,improvedversion. ItistheonlystandardintheISO
14000familythatcanbeusedforcertification. TheISO14000familyincludes21otherstandardsthat
canhelpanorganizationspecificaspectssuchasauditing,environmentallabelling,lifecycleanalysis
15.BENEFITSOFISO9001ANDISO14001 International,expertconsensusonstateoftheart
practicesforqualityandenvironmentalmanagement. Commonlanguagefordealingwithcustomersand
suppliersworldwideinB2B. Increaseefficiencyandeffectiveness. Modelforcontinualimprovement.
16.BENEFITSOFISO9001ANDISO14001(CONT.) Modelforsatisfyingcustomersandother
stakeholders. Buildqualityintoproductsandservicesfromdesignonwards. Addressenvironmental
concernsofcustomersandpublic,andcomplywithgovernmentregulations. Integratewithglobal
economy.
17.BIS
18.INTRODUCTION TheProductCertificationSchemeofBISaimsatprovidingThirdPartyGuarantee
ofquality,safetyandreliability. StandardMarkonaproductisanassuranceofconformity. The
conformityisensuredbyregularsurveillanceofthelicensee'sperformancebysurpriseinspectionsand
testingofsamples,drawnbothfromthemarketandfactory.
19. TheBureauofIndianStandards,empoweredthroughanActoftheIndianParliament,knownasthe
BISAct,1986,operatesaproductcertificationschemebywhichitgrantslicencestomanufacturers
coveringpracticallyeveryindustrialdisciplinefromAgriculturetoTextilestoElectronics. Thecertification
allowsthelicenseestousethepopularISIMark,whichhasbecomesynonymouswithQualityproductsfor
theIndianandneighbouringmarketsoverthelastmorethan55years
20.ABOUTBIS: BIShassetupeightlaboratoriesindifferentcitiesofIndiafortestingsamplesof
productstakenduringpreliminaryandsurveillanceoperations. Inaddition,independentlaboratories
havingdemonstratedabilityandaqualitysystemcomplyingwithISO/IECGuide17025:1999havebeen
recognizedfortestingofsamples. 2500productstestedeveryyear 116totallaboratory Qualityand
standardproducts
21.OBJECTIVESTosafeguardpublichealthTopromoteconsumerconfidenceToprotectconsumerfrom
hazardeousproductToprovidequalityasssurance
22.ACTIVITIES StandardsFormulation Certification Product HallmarkingofGoldJewellery
QualityManagementSystem EnvironmentalManagementSystems HealthandSafetyManagement
System HazardAnalysisandCriticalControlPoints ImportedProducts LaboratoryManagement
InternationalActivitiesBISisamemberofIOforISOandIECIsamemberincouncilboardofIEC
TrainingServices Consumeraffairsandstandardspromotions
23.TYPESOFLICENCINGoTheGovernmentofIndia,onconsiderationsofpublichealthandsafety,
security,infrastructurerequirementsandmassconsumptionhasenforcedmandatorycertificationon
variousproductsthroughOrdersissuedfromtimetotimeundervariousActs.WhileBIScontinuestogrant
licencesonapplication,theenforcementofcompulsorycertificationisdonebythenotifiedauthorities.o
UnderseparatearrangementswithStatutoryagencies,someproductshavebeenplacedunderspecial
certificationschemesoflotorbatchinspectioncarriedoutbyBISInspectingofficers.E.g.Gascylinders,
regulatorsandvalves.
24.AREASFORCERTIFICATION:AreasforCertificationTextilesWoodProductsLeatherProductsRubber
&PlasticCement&ConcreteMachinery&EquipmentAgriculture&FoodBulidingMaterialPumping,
Irrigation&DrainageEquipmentTestingInstrument
25.CERTIFICATIONPROCESSA.GRANTOFLICENSEApplicationPreliminaryInspectionTestingof
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samplesFinalresultsandevaluationGrantofLicense
26.B.MONITORING/SURVEILLANCELicenseeSurpriseVisitsTestinginFactoryMarketSamplesTesting
inIndependentLabsComplaintandFeedbackInvestigationReviewofperformanceLicense
27.DIFFERENCEBETWEENIOS&BIS ISOistheworldslargestdeveloperofinternationalstandards.Is
anetworkofthestandardsinstituteof161countrieswithacentralsecretariatinGeneva,Switzerlandthat
coordinatesthesystem. BISisthenationalstandardsbodyofIndiaresolvestobetheleaderin
standardizationcertificationandqualityinIndia.

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